Teva Pharmacovigilance Recruitment 2023 – Apply Online
Teva Pharmacovigilance manager job opening 2023. M pharma job opening 2023, pharmacy job opening 2023, teva job opening 2023, manager job opening 2023, Candidates with masters degree oin pharma may apply for the job opening at Teva. Check out all the details on the same below:
Job Title: Manager / Senior Pharmacovigilance Manager – ICSR Management (Team Handling/People Management)
Location: Bengaluru, Karnataka, India
Eligbility Criteria & Experience:
- Minimum Master’s degree in Pharmacy or another related field.
- 4 Years minimum people management/team handling experience
- Minimum of 10 years of Biopharmaceutical/CRO industry experience in pharmacovigilance, including a large international organization.
- Knowledge and understanding of relevant GxP requirements applicable for position
- Sound knowledge of pharmacovigilance principles and international regulatory requirements related to drug and patient safety.
- Basic knowledge on TEVA product portfolio, their therapeutic areas expertise, mechanism of actions and its product/patient safety index.
- Fluent in English.
Job-specific Competencies
- Adaptability & Flexibility: The ability to respond positively to change and new ways of working; be prepared to rise to the challenge of dealing with the unfamiliar and cope with the new or unexpected. Effectively address work-related problems, pressures and stresses in a professional and positive way. Ability to adapt, adjust and change to new situations and shift strategies to meet different types of challenges. Can effectively cope with change; can decide and act without having the total picture; can comfortably handle risk and uncertainty.
Team Management
- Cross-functional Communication The ability to communicate ideas, strategies and concerns to cross-functional stakeholders; Understanding of appropriate audience for discussions, and ability to identify appropriate stakeholder for specified messages; Ability to facilitate meetings and drive discussion around a specified agenda ; Ability to articulate a business case;
- Time-management (Prioritization): Ability to handle multiple tasks/projects simultaneously. Determination to stay focused on results and deadlines until the task or project is completed; Spends his/her time and the time of others on what’s important;
- Proactivity: To challenge and lead the organization and self to achieve results and excellence. Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.
- Critical & Analytical Thinking: Having a process of breaking down complex information into components to analyze, interpret, evaluate and construct reasoned arguments in order to solve a problem or reach a conclusion. Breaks down raw information and undefined problems into specific, workable components that in-turn clearly identifies the issues at hand. Makes logical conclusions, anticipates obstacles, and considers different approaches to the decision-making process.
- Results and Performance-Driven: Assumes personal ownership and accountability for business results and solutions; consistently delivers results that meet or exceed expectations; makes the customer central to all thinking; keeps the focus on driving customer value.
- Excellent Communication Skills, both written and Oral: Communication style should be diplomatic and direct, but not confrontational. He or she must be able to summarize information in an articulate, clear, tangible, manner both in written form and orally.
Purpose :
- As Manager/Sr. PV Manager, within the ICSR management sub- function within Patient Safety Operations (PSO), the role in the Global Patient Safety & Pharmacovigilance department within Teva Global R&D (Research & Development) reports to the Head of ICSR Management;
- Drive projects in PSO with impact in Safety processes to identify and implement process simplifications that are aligned to global regulatory requirements.
- Ability to negotiate, resolve conflicts, drive change with PSO ICSR management and its related activities for global/local functions. Strive for simplicity and co-ordinate with relevant working groups for process change and implementation
- The ICSR Transformation expert, is responsible for having an overview of all the processes in ICSR management and ensure the processes are aligned to global regulatory requirements.
- As a process expert, it is required to continuously work on the simplification of the processes with ICSR management and liase with stakeholders with PV units and ensure alignment between units.
- As ICSR transformation expert, should have global oversight of case processing activities, provide guidance to LSO’s and support relevant stakeholders to get aligned to PSO ICSR standards for managing AE’s and SAEs.
- The ICSR transformation Expert is a main contributor to ensure Teva’s ICSR processors are in compliance with laws and regulations to fulfil regulatory compliance and inspection readiness with regards to all ICSR related activities (Global, Regional, Local and Partner), end-to-end, for all Teva products worldwide.
- Responsible for safety database design and functions providing inputs to systems and innovation team that are aligned with global ICSR handling requirements
Mentor and coach case processors in various accepts of ICSR management activities to develop subject matter expertise
Main responsibilities
- Responsible for process overview of ICSR and its related activities globally and support LSO to have local regulations in alignment with global standards for all Teva products
To contribute/support the generation and maintenance of Standard Operating Procedures (SOPs) and Working Instructions (WIs) to ensure optimal operational handling of ICSR and its related activities. - Ability to actively contribute to implementing new regulatory requirements within own role/function to ensure that systems used for safety data reporting comply with international regulatory requirements.
- Strong ability to perform under changing priorities. Participate in internal/cross-functional projects to provide subject matter knowledge
- Extensive knowledge of PV principles and international regulatory requirements regarding drug safety. Knowledge and understanding of relevant GxP requirements. Highly motivated and visionary within the field of expertise
- Excellent ability to communicate, coordinate and execute multiple activities under ICSR management. Assist in Quality KPIs & Metrics activities such as preparing for audits, development of templates, checklists and guidelines
- To act (on request/as assigned) as PSO business owner for any systems or tools implemented as part of the Global PSO and S&I (Systems and Innovation) technology driven strategy.
- Attend and conduct internal meetings with various stake holders and vendors on various queries/ clarification related to ICSR process design and implementation assessment for better awareness amongst case processing groups.
- To establish (on request/as assigned) a strong interface and to define/execute inter function policies/SOPs with all necessary PV interfacing functions (QPPV, Compliance, LSOs/Regions) as well as strong partner collaboration (licensing and service provider partners) to ensure a full oversight.
- To support any Global led guidance to world-wide LSOs wrt local ICSR processes and to foster greater collaboration through Working Groups, LSO Forums and other opportunities.
- Act as process expert with in ICSR transformation team, drive simplification, ensure the activities performed in ICSR management is as per the requirements from global regulatory authorities
- Liaise with Systems and Innovations team in all aspects of data retrieval to develop and maintain active metrics on ICSR workflow and management.
- Actively participate in inspections and audits when required globally and support LSO with local audits/inspections
- Ability to foresee the changes which impacts the system and processes will have on other interfaces and related systems and processes.
- Provide support to EU Qualified Persons for Pharmacovigilance (QPPV) teams as applicable. Signal detections following preparation of Risk Management Programs, PSUR/DSUR surveillance activities, participate in Business Continuity Plans (BCP) as required.
Apply Online
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